- Email: [email protected]
U.S. community pharmacies as CLIA-waived facilities: Prevalence, dispersion, and impact on patient access to testing
Research in Social and Administrative Pharmacy j (2015) j–j
Original Research
U.S. community pharmacies as CLIA-waived facilities: Prevalence, dispersion, and impact on patient access to testing Michael E. Klepser, Pharm.D., F.C.C.P.a, Alex J. Adams, Pharm.D., M.P.H.b,*, Paul Srnis, Pharm.D.(c)c, Matthew Mazzucco, Pharm.D.(c)d, Donald Klepser, Ph.D., M.B.A.e a
Pharmacy Practice, Ferris State University, College of Pharmacy, Kalamazoo, MI, USA Pharmacy Programs, National Association of Chain Drug Stores, Arlington, VA, USAf c Cedarville University, School of Pharmacy, Cedarville, OH, USA d University of Rhode Island, College of Pharmacy, Kingston, RI, USA e Pharmacy Practice, University of Nebraska Medical Center, College of Pharmacy, Omaha, NE, USA b
Abstract Background: The Clinical Laboratory Improvement Amendments of 1988 (CLIA) enabled greater access to low-risk tests by allowing their use in facilities with a Certificate of Waiver in the U.S. Community pharmacies are among the most accessible health professionals, and they are increasingly offering CLIAwaived tests. This manuscript aims to determine: 1) the current number of pharmacies in the United States with CLIA-waivers; 2) the uptake of CLIA-waivers by different pharmacy store types; and 3) the state-bystate differences in the percentage of pharmacies with a CLIA-waiver. Methods: Data were collected from the U.S. Centers for Disease Control and Prevention CLIA Laboratory Search website on May 3rd, 2015. The website allows for exportation of demographic data on all CLIAwaived facilities by state. Results: Pharmacies are currently the fourth highest-ranking facility of CLIA-waived laboratories with 10,838 locations. Supermarkets had the highest percentage of pharmacies with a CLIA-waiver (43.16%). States demonstrated considerable variability in the percentage of pharmacies with a CLIA-waiver, with a median percentage of 19.56% (0%–60.00% range). Conclusions: Community pharmacies are currently a leading facility for CLIA-waived laboratories. Substantial state-level variation is observed in the percentage of pharmacies with CLIA-waivers, and these
Funding support: None. Conflicts of interest: N/A. Disclaimer: The views expressed in this manuscript are those of the authors alone, and do not necessarily reflect those of their respective employers. f At the time of writing. * Corresponding author. E-mail address: [email protected] (A.J. Adams). 1551-7411/$ - see front matter Ó 2015 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.sapharm.2015.09.006
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differences may be driven by restrictions in state law or regulations. Ó 2015 Elsevier Inc. All rights reserved. Keywords: Community pharmacy; Point-of-care testing; CLIA-waived laboratories
Introduction The U.S. Clinical Laboratory Improvement Amendments of 1988 (CLIA) enabled greater access to simple, low-risk tests by allowing their use in facilities with a Certificate of Waiver.1 The number of analytes for which CLIA-waived test systems are available has grown from nine in 1993, to 123 in 2015 as a result of rapid innovation in technology.1,2 CLIA-waived tests are now available to detect pregnancy, diagnose influenza, screen for substance abuse, or monitor patients with diabetes, among other uses. Further growth in the number of CLIA-waived tests available is expected in the years ahead. Convenient access to CLIA-waived tests can aid in diagnosis and speed time to treatment. Increased access to CLIA-waived tests thus has the potential to enhance patient care. The number of access points for CLIA-waived tests in facilities with a CLIA Certificate of Waiver has seen rapid growth, from 67,294 in 1993, to 170,404 in November 2014.3 Common CLIA-waived facilities include physician offices, skilled nursing facilities, home health agencies, community clinics, and ambulances.4 Increasingly, CLIA-waived tests are also being offered at community pharmacies. One of the potential benefits of pharmacy-based testing is accessibility. Community pharmacists are among the most accessible health professionals in the United States, with 95% of all Americans living within 5 miles of a pharmacy.5,6 Community pharmacies are increasingly offering an expanded suite of clinical services; for example, the number of pharmacybased immunizations has grown rapidly, and 1 in 5 flu shots is now given in pharmacies partly as a result of their reach and accessibility.7 Similar growth in access may be possible for CLIA-waived testing. Previous literature has reported on pharmacy-based CLIA-waived testing for influenza, Group A Streptococcus, Human Immunodeficiency Virus, Hepatitis C, hemoglobin A1c, cholesterol, and Heliobacter pylori, among others.8–18 In the 2014 National Pharmacist Workforce survey, 29% of respondents indicated that
they conduct “health screening,” 14% reported that they conduct point-of-care testing, and 33% reported that they order laboratory tests.19 While studies have documented individual CLIA-waived tests that have been leveraged in community pharmacies, a national benchmark report of the prevalence and dispersion of community pharmacies as CLIA-waived facilities has not been reported beyond surveys. This study thus aimed to determine: 1) the current number of pharmacies in the United States with CLIA Certificates of Waiver; 2) the differences in uptake of CLIA-waivers by different pharmacy store types; and 3) the state-by-state differences in the percentage of pharmacies with CLIA Certificates of Waiver.
Methods For the purposes of this study, we counted all facilities that held either a CLIA Certificate of Waiver or higher credential (e.g., Certificate of Accreditation, Certificate of Compliance) as a CLIA-waived facility, as those facilities holding these higher credentials may also perform CLIAwaived tests. To determine the number of CLIAwaived facilities by facility type nationally, and the number of pharmacies with a CLIA-waiver in each state, data were collected from the Centers for Disease Control and Prevention (CDC) CLIA Laboratory Search website on May 3rd, 2015.20 The CDC website allows for a search of CLIAwaived laboratories and includes city, state, zip code, laboratory type (i.e., hospital, physician’s office, pharmacy, etc.), and certificate type (i.e., waiver, accredited, etc.). The authors of the current study conducted searches for all laboratory types and all certificate types for each of the 50 states and the District of Columbia, individually. The results from each state search were exported from the CDC webpage into a Microsoft ExcelÒ spreadsheet for further analysis. Applicants for a CLIA-waiver are required to report their “type of laboratory” that is most descriptive of their facility type. Twenty-nine choices are given for type of facility, one of which
Klepser et al. / Research in Social and Administrative Pharmacy j (2015) 1–8
is “pharmacy.” The investigators leveraged this self-reported facility type to identify the facilities with the most number of CLIA-waivers and the number of CLIA-waived laboratories in each state that are in pharmacies. This was ensued by a calculation of the percentage of pharmacies in each state that have a CLIA-waiver using data on the total number of pharmacies in each state available in the National Association of Chain Drug Stores (NACDS) Fact Book published in July 2014.21 The investigators treated all selfreported CLIA-waived pharmacies as community pharmacies for the purposes of calculating this percentage. Pharmacies were also classified by two investigators (M.M. & P.S.) according to their type of store: independent, traditional chain, supermarket with pharmacy, or mass merchant with pharmacy. The percentage of pharmacies with CLIA-waivers by store type was also calculated using data from NACDS0 Fact Book published in July 2014.21 Results Current number of pharmacies with CLIA-waivers Across the U.S., a total of 200,383 facilities with CLIA-waived testing are recorded, of which 10,838 are located in pharmacies (5.41%). Pharmacies were the fourth highest-ranking facility of CLIA-waived laboratories by number, following physician offices (122,634; 61.20%), home health agencies (14,948; 7.46%), and skilled nursing facilities (14,467; 7.22%) (Table 1).
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Differences in CLIA-waivers by pharmacy store type Chart 1 shows a break-down of pharmacies with CLIA-waivers by store type. Supermarkets had the highest percentage of pharmacies with a CLIA-waiver, accounting for 43.16% of all supermarket locations. By contrast, only 3.83% of mass merchant pharmacies held a CLIA-waiver. State-by-state differences in pharmacies with CLIA-waivers Table 2 reports the number of community pharmacies with CLIA-waivers by state. The number of such pharmacies varied substantially by state, with a median of 129 pharmacies (0– 1184, range). The states with the most pharmacies with CLIA-waivers were: 1) Texas (1184 pharmacies); 2) Florida (1020 pharmacies); and 3) California (779 pharmacies). Fifteen states had fewer than 50 pharmacies with CLIA-waivers in the state. Nationally, 17.94% of all pharmacies had a CLIA-waiver. States demonstrated considerable variability, with a median percentage of 19.56% of pharmacies holding a CLIA-waiver (0%– 60.00% range). The states with the highest percentage of pharmacies in the state with a CLIAwaiver were: 1) Alaska (60.00%); 2) Washington (48.60%); and 3) North Dakota (37.61%). The states with the lowest percentage of pharmacies with a CLIA-waiver were: 1) Nevada (0%); 2) Massachusetts (0.27%); and 3) New York (0.40%). Fig. 1 presents a color-coded map of the United States depicting the state-level
Table 1 Top laboratory settings by facility count Rank
Type of facility
Number of facilities in U.S. with CLIA-waiver or higher credential as of May 2015
Percent of laboratories that are CLIA-waived only
1. 2. 3. 4. 5. 6. 7. 8. 9. 10.
Physician office Skilled nursing facility/Nursing facility Home health agency Pharmacy Hospital Community clinic End stage renal disease facility Ambulatory surgery center Independent Ambulance
122,634 14,948 14,467 10,838 9060 7154 5990 5775 5424 4093
61.90% 99.13% 99.77% 99.85% 20.87% 51.61% 99.43% 92.54% 22.31% 99.07%
Facilities are counted as having a CLIA-waiver if they have a CLIA Certificate of Waiver or a higher credential (e.g., Certificate of Accreditation, Certificate of Compliance). Excludes categories of “Other” and “Other Practitioner”. Source: Centers for Disease Control and Prevention (CDC). CLIA Laboratory Search. Retrieved from: http:// wwwn.cdc.gov/clia/Resources/LabSearch.aspx; Accessed 03.05.15.
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Percentage of Pharmacies with CLIA Waivers
4
50.00 45.00
43.16
40.00 35.00 30.00 25.00
23.71
20.00 15.00 10.00 5.00 0.00
5.39
3.83
Independents Mass Merchants Supermarkets
Traditional Chains
Chart 1. Percentage of U.S. Pharmacies with CLIA-waivers, by store type. Sources: Centers for Disease Control and Prevention (CDC). CLIA Laboratory Search. Retrieved from: http://wwwn.cdc.gov/clia/Resources/LabSearch.aspx; Accessed 03.05.15. National Association of Chain Drug Stores. Chain Member Fact Book, 2014–2015. July 2015.
variation in percentage of pharmacies with a CLIA-waiver. Discussion Community pharmacies are currently the fourth leading facility with CLIA-waived laboratories in the United States, with 10,838 current locations with Certificates of Waiver. Substantial growth potential exists, as only 17.94% of all pharmacies currently hold a CLIA-waiver. With nearly 60,000 community pharmacies across the nation, modest growth scenarios are likely to move pharmacies to the second leading facility for CLIA-waived laboratories in the years ahead. In addition to geographic access, pharmacies are often open on nights, weekends, and holidays, and this could further augment patient access and care. For example, early evidence from studies on pharmacy-based CLIA-waived testing for influenza and Group A Strep demonstrated that a substantial fraction of tests were provided outside traditional physician office hours (39% and 43.9%, respectively), and many of the patients seeking testing did not have a primary care physician (35% and 44%, respectively).10 These studies further demonstrated high levels of patient satisfaction with CLIA-waived testing in pharmacies.10 The percentage of pharmacies with a CLIAwaiver varied significantly by state, ranging from
0% to 60%. There are many factors that may impact the decision of a pharmacy to apply for a CLIA-waiver. These include, but are not limited to, market demand, coverage from health insurers, and differences in practice environment, such as semi-private areas, that may make the provision of CLIA-waived tests more or less likely. While there may be some regional variation that governs these aforementioned factors, they are unlikely to alone account for such substantial state variation. A more likely cause is the difference in state laws and regulations governing CLIA-waived facilities. While many states mirror federal CLIA restrictions alone and allow any facility who obtains a CMS Certificate of Waiver to become a waived facility, some states impose additional statespecific restrictions or prevent pharmacies from becoming providers altogether. Nevada, New York, and Rhode Island currently place substantial legal barriers to pharmacies becoming CLIAwaived facilities, which accounts for the low amount of pharmacies with CLIA-waivers in these states (0%, 0.40% and 0.53%, respectively). Other states, like Pennsylvania, include burdensome restrictions on who can become a director of a clinical laboratory, and as a result, only 1.66% of pharmacies in the state have a CLIA-waiver.22 The gains in patient access that are possible in these states are substantial if such restrictive laws are changed to mirror only federal CLIA restrictions. In New York alone, if 60% of the pharmacies
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Table 2 State-by-state analysis of community pharmacies as CLIA-waived facilities State
Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware District of Columbia Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia
Total number of community pharmacies with CLIA-waivers in state 133 48 363 88 779 213 23 52 15 1020 288 12 102 668 319 231 140 245 153 3 165 3 440 243 92 375 53 93 0 26 191 74 17 293 41 421 89 129 45 1 180 27 301 1184 156 14 332 522 108
Overall percentage of community pharmacies with CLIA-waiver
Difference in percentage between state and national average
10.48% 60.00% 36.52% 12.94% 13.84% 28.44% 3.59% 27.51% 11.90% 24.05% 14.10% 6.19% 37.50% 31.73% 28.92% 34.79% 21.71% 24.14% 14.74% 1.08% 14.96% 0.27% 19.56% 25.80% 9.47% 32.00% 25.12% 23.08% 0.00% 10.36% 10.24% 26.81% 0.40% 15.17% 37.61% 20.23% 11.44% 21.72% 1.66% 0.53% 17.95% 15.88% 20.60% 27.19% 33.69% 11.02% 22.48% 48.60% 20.57%
7.46% 42.06% 18.58% 5.00% 4.10% 10.50% 14.35% 9.57% 6.04% 6.11% 3.84% 11.75% 19.56% 13.79% 10.98% 16.85% 3.77% 6.20% 3.20% 16.86% 2.98% 17.67% 1.62% 7.86% 8.47% 14.06% 7.18% 5.14% 17.94% 7.58% 7.70% 8.87% 17.54% 2.77% 19.67% 2.29% 6.50% 3.78% 16.28% 17.41% 0.01% 2.06% 2.66% 9.25% 15.75% 6.92% 4.54% 30.66% 2.63% (continued)
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Table 2 (continued ) State
Total number of community pharmacies with CLIA-waivers in state
Overall percentage of community pharmacies with CLIA-waiver
Wisconsin Wyoming Totals
98 18 10,626
10.33% 16.67% 17.94%
Difference in percentage between state and national average 7.61% 1.27%
Sources: Centers for Disease Control and Prevention (CDC). CLIA Laboratory Search. Retrieved from: http:// wwwn.cdc.gov/clia/Resources/LabSearch.aspx; Accessed 03.05.15. National Association of Chain Drug Stores. Chain Member Fact Book, 2014–2015. July 2015.
had CLIA-waivers, as is the case in Alaska, a total of 2504 new facilities would be available to members of the general public. Across all states, this model would yield 24,910 net new facilities with CLIA-waived testing available to the general public. The authors believe that this model, which projects 60% of pharmacies holding a CLIA-waiver to be conservative given the current state of immunizations in pharmacy, which is estimated to be available at 95% of traditional chain pharmacies, 92% of mass merchants, and 93% of supermarkets with pharmacies.19 State-level variation in laws enabling Collaborative Practice Agreements (CPAs) may further limit uptake of CLIA-waived testing in pharmacies. Conducting a CLIAwaived test is just one piece of the puzzle; acting on the result of the test is where value is likely to be derived.23 For certain tests, acting on the result of the test may necessitate the initiation or
modification of a prescription medication. As pharmacists do not have prescriptive authority in most instances, a CPA is critical to enabling appropriate action by a pharmacist on the result of a test. Many states limit the use of CPAs to institutional facilities only, or to post-diagnostic care, among other restrictions, which can impede uptake in community pharmacy settings.24,25 Future research should thus explore the connection between state laws and regulations that impede pharmacies from becoming CLIA-waived facilities or acting on the results of tests under a CPA. Still, even in states with few apparent restrictions on pharmacy-based CLIA-waived testing or CPAs, variation in the percentage of pharmacies with CLIA-waivers exists. This may be due to the lack of awareness of opportunities. State pharmacy associations and other stakeholders have a valuable role to play in ensuring pharmacies in their state
Fig. 1. Overall percentage of U.S. community pharmacies with a CLIA-waiver, by state. Sources: Centers for Disease Control and Prevention (CDC). CLIA Laboratory Search. Retrieved from: http://wwwn.cdc.gov/clia/Resources/LabSearch. aspx; Accessed 03.05.15. National Association of Chain Drug Stores. Chain Member Fact Book, 2014–2015. July 2015.
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are aware of the opportunities that exist. Additional efforts to create template protocols and CPAs may further help pharmacies by lowering the activation barrier of getting involved. Limitations One limitation to this research is that data pulled for the study represent different points in time. For example, the number of total community pharmacies in the country was pulled from the most recent NACDS Facts Book that reports data from 2013. The current CLIA-waived facilities data was pulled in May of 2015. It would be ideal if the timing of these datasets were synchronized; however, we do not believe there would be substantial variance per state, and thus believe the data provide a useful benchmark and comparison across states. Additionally, the assumption is made that every self-reported pharmacy with a CLIA-waiver is actively providing CLIA-waived tests. Some pharmacies that obtain such waiver may in fact not provide any test, or have an extremely limited test menu. Additional research on the types of tests that are provided in pharmacies, relative to other settings, is warranted, as well as a comparison of location in rural areas and hours of operation across settings. Conclusion Community pharmacies in the U.S. are leading facilities for CLIA-waived laboratories. Substantial state-level variations are observed in the percentage of pharmacies with CLIA Certificates of Waiver, and these differences may be driven by restrictions in state law or regulations. References 1. Centers for Disease Control and Prevention (CDC). Good laboratory practices for waived testing sites. MMWR; November 11, 2015. p. 1. Available from: http://www.cdc.gov/mmwr/PDF/rr/rr5413.pdf. Accessed July 2015. 2. U.S. Food and Drug Administration. Clinical Laboratory Amendments (CLIA) – currently waived analytes. Available from: http://www.accessdata.fda. gov/scripts/cdrh/cfdocs/cfclia/analyteswaived.cfm. Accessed July 2015. 3. Centers for Medicare and Medicaid Services (CMS). CLIA Database Information – 1993–2014; November 2014. Available from: http://www.cms.gov/Regula tions-and-Guidance/Legislation/CLIA/Downloads/ summary_chart1993_to2013.pdf. Accessed July 2015.
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4. Centers for Medicare and Medicaid Services (CMS). Laboratories by Type of Facility. CLIA Update; November 2014. Available from: http://www.cms. gov/Regulations-and-Guidance/Legislation/CLIA/ Downloads/factype.pdf. Accessed July 2015. 5. Rosenfeld LA, Etkind P, Grasso A, Adams AJ, Rothholz MC. Extending the reach: local health department collaboration with community pharmacies in Palm Beach County, Florida for H1N1 influenza pandemic response. J Public Health Manag Pract 2011;17:439–448. 6. Rubin SE, Schulman RM, Roszak AR, Herrmann J, Patel A, Koonin LM. Leveraging partnerships among community pharmacists, pharmacies, and health departments to improve pandemic influenza response. Health Secur 2014;12:76–84. 7. Centers for Disease Control and Prevention. Place of influenza vaccination among adults – United States, 2010-11 influenza season. MMWR; June 17, 2011. p. 782. 8. Akinwale TP, Adams AJ, Dering-Anderson AM, Klepser ME. Pharmacy-based point-of-care testing for infectious diseases: considerations for the pharmacy curriculum. Curr Pharm Teach Learn 2015;7: 131–136. 9. Gubbins PO, Klepser ME, Dering-Anderson AM, et al. Point-of-care testing for infectious diseases: opportunities, barriers, and considerations in community pharmacy. J Am Pharm Assoc 2014;54: 163–171. 10. Klepser ME, Adams AJ, Klepser DG. Antimicrobial stewardship in outpatient settings: leveraging innovative physician-pharmacist collaborations to reduce antibiotic resistance. Health Secur; 2015;166–173. 11. Roberts GE, Rubin SE, Smith JK, Adams AJ, Klepser DG. Public health perceptions of community pharmacy partnership opportunities. J Public Health Manag Pract; 2015;413–415. 12. Weidle PJ, Lecher S, Botts LW, et al. HIV testing in community pharmacies and retail clinics: a model to expand access to screening for HIV infection. J Am Pharm Assoc 2014;54:486–492. 13. Darin KM, Klepser ME, Klepser DE, et al. Pharmacist-provided rapid HIV testing in two community pharmacies. J Am Pharm Assoc 2015;55:81–88. 14. The Hepatitis C Trust. Pharmacy-based testing for hepatitis B and hepatitis C. Available from: http:// www.hcvaction.org.uk/sites/default/files/resources/ Pharmacy-based%20testing%20for%20hepatitis% 20B%20and%20hepatitis%20C%20%28hep%20c %20trust%29.pdf. Accessed July 2015. 15. Snella KA. Pharmacy- and community-based screenings for diabetes and cardiovascular conditions in high-risk individuals. J Am Pharm Assoc 2006;46:307–317. 16. Fera T, Bluml BM, Ellis WM, Schaller CW, Garrett DG. The Diabetes Ten City Challenge: interim clinical and humanistic outcomes of a multisite pharmacy diabetes care program. J Am Pharm Assoc 2008;48:181–190.
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17. North Sheffield Primary Care Trust. Community Pharmacy Helicobacter Pylori ‘Test and Treat’ Enhanced Service Specification; December 2005. 18. Attard D, Azzopardi LM, Serracino-Inglott A. Proposing a Point-of-Care testing service for H. Pylori in community pharmacies. Retrieved from: https:// www.um.edu.mt/__data/assets/pdf_file/0010/194419/ Daniel_Attard_Poster.pdf. Accessed July 2015. 19. Midwest Pharmacy Workforce Research Consortium. 2014 National Pharmacist Workforce Survey. Available from: http://www.aacp.org/resources/research/ pharmacyworkforcecenter/Documents/FinalReport OfTheNationalPharmacistWorkforceStudy2014.pdf. Accessed July 2015. 20. Centers for Disease Control and Prevention (CDC). CLIA laboratory search. Available from: http:// wwwn.cdc.gov/clia/Resources/LabSearch.aspx. Accessed July 2015.
21. National Association of Chain Drug Stores. Chain Member Fact Book, 2014-2015; July 2014. 22. Pennsylvania Department of Health. Bureau of laboratories. Available from: http://www.portal.state.pa. us/portal/server.pt/community/laboratories/14158/ clinical_lab_licensure/556786. Accessed July 2015. 23. Adams AJ. Toward permissionless innovation in health care. J Am Pharm Assoc 2015;55:359–362. 24. Adams AJ, Klepser M, Klepser D. Physician-pharmacist collaborative practice agreements: a strategy to improve adherence to evidence-based guidelines. Evid Based Med Public Health 2015;1:e923. http:// dx.doi.org/10.14800/emph.923. 25. Centers for Disease Control and Prevention. Collaborative Practice Agreements and Pharmacists’ Patient Care Services. Available from: http://www.cdc. gov/dhdsp/pubs/docs/Translational_Tools_Pharma cists.pdf. Accessed July 2015.
Original Research
U.S. community pharmacies as CLIA-waived facilities: Prevalence, dispersion, and impact on patient access to testing Michael E. Klepser, Pharm.D., F.C.C.P.a, Alex J. Adams, Pharm.D., M.P.H.b,*, Paul Srnis, Pharm.D.(c)c, Matthew Mazzucco, Pharm.D.(c)d, Donald Klepser, Ph.D., M.B.A.e a
Pharmacy Practice, Ferris State University, College of Pharmacy, Kalamazoo, MI, USA Pharmacy Programs, National Association of Chain Drug Stores, Arlington, VA, USAf c Cedarville University, School of Pharmacy, Cedarville, OH, USA d University of Rhode Island, College of Pharmacy, Kingston, RI, USA e Pharmacy Practice, University of Nebraska Medical Center, College of Pharmacy, Omaha, NE, USA b
Abstract Background: The Clinical Laboratory Improvement Amendments of 1988 (CLIA) enabled greater access to low-risk tests by allowing their use in facilities with a Certificate of Waiver in the U.S. Community pharmacies are among the most accessible health professionals, and they are increasingly offering CLIAwaived tests. This manuscript aims to determine: 1) the current number of pharmacies in the United States with CLIA-waivers; 2) the uptake of CLIA-waivers by different pharmacy store types; and 3) the state-bystate differences in the percentage of pharmacies with a CLIA-waiver. Methods: Data were collected from the U.S. Centers for Disease Control and Prevention CLIA Laboratory Search website on May 3rd, 2015. The website allows for exportation of demographic data on all CLIAwaived facilities by state. Results: Pharmacies are currently the fourth highest-ranking facility of CLIA-waived laboratories with 10,838 locations. Supermarkets had the highest percentage of pharmacies with a CLIA-waiver (43.16%). States demonstrated considerable variability in the percentage of pharmacies with a CLIA-waiver, with a median percentage of 19.56% (0%–60.00% range). Conclusions: Community pharmacies are currently a leading facility for CLIA-waived laboratories. Substantial state-level variation is observed in the percentage of pharmacies with CLIA-waivers, and these
Funding support: None. Conflicts of interest: N/A. Disclaimer: The views expressed in this manuscript are those of the authors alone, and do not necessarily reflect those of their respective employers. f At the time of writing. * Corresponding author. E-mail address: [email protected] (A.J. Adams). 1551-7411/$ - see front matter Ó 2015 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.sapharm.2015.09.006
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differences may be driven by restrictions in state law or regulations. Ó 2015 Elsevier Inc. All rights reserved. Keywords: Community pharmacy; Point-of-care testing; CLIA-waived laboratories
Introduction The U.S. Clinical Laboratory Improvement Amendments of 1988 (CLIA) enabled greater access to simple, low-risk tests by allowing their use in facilities with a Certificate of Waiver.1 The number of analytes for which CLIA-waived test systems are available has grown from nine in 1993, to 123 in 2015 as a result of rapid innovation in technology.1,2 CLIA-waived tests are now available to detect pregnancy, diagnose influenza, screen for substance abuse, or monitor patients with diabetes, among other uses. Further growth in the number of CLIA-waived tests available is expected in the years ahead. Convenient access to CLIA-waived tests can aid in diagnosis and speed time to treatment. Increased access to CLIA-waived tests thus has the potential to enhance patient care. The number of access points for CLIA-waived tests in facilities with a CLIA Certificate of Waiver has seen rapid growth, from 67,294 in 1993, to 170,404 in November 2014.3 Common CLIA-waived facilities include physician offices, skilled nursing facilities, home health agencies, community clinics, and ambulances.4 Increasingly, CLIA-waived tests are also being offered at community pharmacies. One of the potential benefits of pharmacy-based testing is accessibility. Community pharmacists are among the most accessible health professionals in the United States, with 95% of all Americans living within 5 miles of a pharmacy.5,6 Community pharmacies are increasingly offering an expanded suite of clinical services; for example, the number of pharmacybased immunizations has grown rapidly, and 1 in 5 flu shots is now given in pharmacies partly as a result of their reach and accessibility.7 Similar growth in access may be possible for CLIA-waived testing. Previous literature has reported on pharmacy-based CLIA-waived testing for influenza, Group A Streptococcus, Human Immunodeficiency Virus, Hepatitis C, hemoglobin A1c, cholesterol, and Heliobacter pylori, among others.8–18 In the 2014 National Pharmacist Workforce survey, 29% of respondents indicated that
they conduct “health screening,” 14% reported that they conduct point-of-care testing, and 33% reported that they order laboratory tests.19 While studies have documented individual CLIA-waived tests that have been leveraged in community pharmacies, a national benchmark report of the prevalence and dispersion of community pharmacies as CLIA-waived facilities has not been reported beyond surveys. This study thus aimed to determine: 1) the current number of pharmacies in the United States with CLIA Certificates of Waiver; 2) the differences in uptake of CLIA-waivers by different pharmacy store types; and 3) the state-by-state differences in the percentage of pharmacies with CLIA Certificates of Waiver.
Methods For the purposes of this study, we counted all facilities that held either a CLIA Certificate of Waiver or higher credential (e.g., Certificate of Accreditation, Certificate of Compliance) as a CLIA-waived facility, as those facilities holding these higher credentials may also perform CLIAwaived tests. To determine the number of CLIAwaived facilities by facility type nationally, and the number of pharmacies with a CLIA-waiver in each state, data were collected from the Centers for Disease Control and Prevention (CDC) CLIA Laboratory Search website on May 3rd, 2015.20 The CDC website allows for a search of CLIAwaived laboratories and includes city, state, zip code, laboratory type (i.e., hospital, physician’s office, pharmacy, etc.), and certificate type (i.e., waiver, accredited, etc.). The authors of the current study conducted searches for all laboratory types and all certificate types for each of the 50 states and the District of Columbia, individually. The results from each state search were exported from the CDC webpage into a Microsoft ExcelÒ spreadsheet for further analysis. Applicants for a CLIA-waiver are required to report their “type of laboratory” that is most descriptive of their facility type. Twenty-nine choices are given for type of facility, one of which
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is “pharmacy.” The investigators leveraged this self-reported facility type to identify the facilities with the most number of CLIA-waivers and the number of CLIA-waived laboratories in each state that are in pharmacies. This was ensued by a calculation of the percentage of pharmacies in each state that have a CLIA-waiver using data on the total number of pharmacies in each state available in the National Association of Chain Drug Stores (NACDS) Fact Book published in July 2014.21 The investigators treated all selfreported CLIA-waived pharmacies as community pharmacies for the purposes of calculating this percentage. Pharmacies were also classified by two investigators (M.M. & P.S.) according to their type of store: independent, traditional chain, supermarket with pharmacy, or mass merchant with pharmacy. The percentage of pharmacies with CLIA-waivers by store type was also calculated using data from NACDS0 Fact Book published in July 2014.21 Results Current number of pharmacies with CLIA-waivers Across the U.S., a total of 200,383 facilities with CLIA-waived testing are recorded, of which 10,838 are located in pharmacies (5.41%). Pharmacies were the fourth highest-ranking facility of CLIA-waived laboratories by number, following physician offices (122,634; 61.20%), home health agencies (14,948; 7.46%), and skilled nursing facilities (14,467; 7.22%) (Table 1).
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Differences in CLIA-waivers by pharmacy store type Chart 1 shows a break-down of pharmacies with CLIA-waivers by store type. Supermarkets had the highest percentage of pharmacies with a CLIA-waiver, accounting for 43.16% of all supermarket locations. By contrast, only 3.83% of mass merchant pharmacies held a CLIA-waiver. State-by-state differences in pharmacies with CLIA-waivers Table 2 reports the number of community pharmacies with CLIA-waivers by state. The number of such pharmacies varied substantially by state, with a median of 129 pharmacies (0– 1184, range). The states with the most pharmacies with CLIA-waivers were: 1) Texas (1184 pharmacies); 2) Florida (1020 pharmacies); and 3) California (779 pharmacies). Fifteen states had fewer than 50 pharmacies with CLIA-waivers in the state. Nationally, 17.94% of all pharmacies had a CLIA-waiver. States demonstrated considerable variability, with a median percentage of 19.56% of pharmacies holding a CLIA-waiver (0%– 60.00% range). The states with the highest percentage of pharmacies in the state with a CLIAwaiver were: 1) Alaska (60.00%); 2) Washington (48.60%); and 3) North Dakota (37.61%). The states with the lowest percentage of pharmacies with a CLIA-waiver were: 1) Nevada (0%); 2) Massachusetts (0.27%); and 3) New York (0.40%). Fig. 1 presents a color-coded map of the United States depicting the state-level
Table 1 Top laboratory settings by facility count Rank
Type of facility
Number of facilities in U.S. with CLIA-waiver or higher credential as of May 2015
Percent of laboratories that are CLIA-waived only
1. 2. 3. 4. 5. 6. 7. 8. 9. 10.
Physician office Skilled nursing facility/Nursing facility Home health agency Pharmacy Hospital Community clinic End stage renal disease facility Ambulatory surgery center Independent Ambulance
122,634 14,948 14,467 10,838 9060 7154 5990 5775 5424 4093
61.90% 99.13% 99.77% 99.85% 20.87% 51.61% 99.43% 92.54% 22.31% 99.07%
Facilities are counted as having a CLIA-waiver if they have a CLIA Certificate of Waiver or a higher credential (e.g., Certificate of Accreditation, Certificate of Compliance). Excludes categories of “Other” and “Other Practitioner”. Source: Centers for Disease Control and Prevention (CDC). CLIA Laboratory Search. Retrieved from: http:// wwwn.cdc.gov/clia/Resources/LabSearch.aspx; Accessed 03.05.15.
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Percentage of Pharmacies with CLIA Waivers
4
50.00 45.00
43.16
40.00 35.00 30.00 25.00
23.71
20.00 15.00 10.00 5.00 0.00
5.39
3.83
Independents Mass Merchants Supermarkets
Traditional Chains
Chart 1. Percentage of U.S. Pharmacies with CLIA-waivers, by store type. Sources: Centers for Disease Control and Prevention (CDC). CLIA Laboratory Search. Retrieved from: http://wwwn.cdc.gov/clia/Resources/LabSearch.aspx; Accessed 03.05.15. National Association of Chain Drug Stores. Chain Member Fact Book, 2014–2015. July 2015.
variation in percentage of pharmacies with a CLIA-waiver. Discussion Community pharmacies are currently the fourth leading facility with CLIA-waived laboratories in the United States, with 10,838 current locations with Certificates of Waiver. Substantial growth potential exists, as only 17.94% of all pharmacies currently hold a CLIA-waiver. With nearly 60,000 community pharmacies across the nation, modest growth scenarios are likely to move pharmacies to the second leading facility for CLIA-waived laboratories in the years ahead. In addition to geographic access, pharmacies are often open on nights, weekends, and holidays, and this could further augment patient access and care. For example, early evidence from studies on pharmacy-based CLIA-waived testing for influenza and Group A Strep demonstrated that a substantial fraction of tests were provided outside traditional physician office hours (39% and 43.9%, respectively), and many of the patients seeking testing did not have a primary care physician (35% and 44%, respectively).10 These studies further demonstrated high levels of patient satisfaction with CLIA-waived testing in pharmacies.10 The percentage of pharmacies with a CLIAwaiver varied significantly by state, ranging from
0% to 60%. There are many factors that may impact the decision of a pharmacy to apply for a CLIA-waiver. These include, but are not limited to, market demand, coverage from health insurers, and differences in practice environment, such as semi-private areas, that may make the provision of CLIA-waived tests more or less likely. While there may be some regional variation that governs these aforementioned factors, they are unlikely to alone account for such substantial state variation. A more likely cause is the difference in state laws and regulations governing CLIA-waived facilities. While many states mirror federal CLIA restrictions alone and allow any facility who obtains a CMS Certificate of Waiver to become a waived facility, some states impose additional statespecific restrictions or prevent pharmacies from becoming providers altogether. Nevada, New York, and Rhode Island currently place substantial legal barriers to pharmacies becoming CLIAwaived facilities, which accounts for the low amount of pharmacies with CLIA-waivers in these states (0%, 0.40% and 0.53%, respectively). Other states, like Pennsylvania, include burdensome restrictions on who can become a director of a clinical laboratory, and as a result, only 1.66% of pharmacies in the state have a CLIA-waiver.22 The gains in patient access that are possible in these states are substantial if such restrictive laws are changed to mirror only federal CLIA restrictions. In New York alone, if 60% of the pharmacies
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Table 2 State-by-state analysis of community pharmacies as CLIA-waived facilities State
Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware District of Columbia Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia
Total number of community pharmacies with CLIA-waivers in state 133 48 363 88 779 213 23 52 15 1020 288 12 102 668 319 231 140 245 153 3 165 3 440 243 92 375 53 93 0 26 191 74 17 293 41 421 89 129 45 1 180 27 301 1184 156 14 332 522 108
Overall percentage of community pharmacies with CLIA-waiver
Difference in percentage between state and national average
10.48% 60.00% 36.52% 12.94% 13.84% 28.44% 3.59% 27.51% 11.90% 24.05% 14.10% 6.19% 37.50% 31.73% 28.92% 34.79% 21.71% 24.14% 14.74% 1.08% 14.96% 0.27% 19.56% 25.80% 9.47% 32.00% 25.12% 23.08% 0.00% 10.36% 10.24% 26.81% 0.40% 15.17% 37.61% 20.23% 11.44% 21.72% 1.66% 0.53% 17.95% 15.88% 20.60% 27.19% 33.69% 11.02% 22.48% 48.60% 20.57%
7.46% 42.06% 18.58% 5.00% 4.10% 10.50% 14.35% 9.57% 6.04% 6.11% 3.84% 11.75% 19.56% 13.79% 10.98% 16.85% 3.77% 6.20% 3.20% 16.86% 2.98% 17.67% 1.62% 7.86% 8.47% 14.06% 7.18% 5.14% 17.94% 7.58% 7.70% 8.87% 17.54% 2.77% 19.67% 2.29% 6.50% 3.78% 16.28% 17.41% 0.01% 2.06% 2.66% 9.25% 15.75% 6.92% 4.54% 30.66% 2.63% (continued)
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Table 2 (continued ) State
Total number of community pharmacies with CLIA-waivers in state
Overall percentage of community pharmacies with CLIA-waiver
Wisconsin Wyoming Totals
98 18 10,626
10.33% 16.67% 17.94%
Difference in percentage between state and national average 7.61% 1.27%
Sources: Centers for Disease Control and Prevention (CDC). CLIA Laboratory Search. Retrieved from: http:// wwwn.cdc.gov/clia/Resources/LabSearch.aspx; Accessed 03.05.15. National Association of Chain Drug Stores. Chain Member Fact Book, 2014–2015. July 2015.
had CLIA-waivers, as is the case in Alaska, a total of 2504 new facilities would be available to members of the general public. Across all states, this model would yield 24,910 net new facilities with CLIA-waived testing available to the general public. The authors believe that this model, which projects 60% of pharmacies holding a CLIA-waiver to be conservative given the current state of immunizations in pharmacy, which is estimated to be available at 95% of traditional chain pharmacies, 92% of mass merchants, and 93% of supermarkets with pharmacies.19 State-level variation in laws enabling Collaborative Practice Agreements (CPAs) may further limit uptake of CLIA-waived testing in pharmacies. Conducting a CLIAwaived test is just one piece of the puzzle; acting on the result of the test is where value is likely to be derived.23 For certain tests, acting on the result of the test may necessitate the initiation or
modification of a prescription medication. As pharmacists do not have prescriptive authority in most instances, a CPA is critical to enabling appropriate action by a pharmacist on the result of a test. Many states limit the use of CPAs to institutional facilities only, or to post-diagnostic care, among other restrictions, which can impede uptake in community pharmacy settings.24,25 Future research should thus explore the connection between state laws and regulations that impede pharmacies from becoming CLIA-waived facilities or acting on the results of tests under a CPA. Still, even in states with few apparent restrictions on pharmacy-based CLIA-waived testing or CPAs, variation in the percentage of pharmacies with CLIA-waivers exists. This may be due to the lack of awareness of opportunities. State pharmacy associations and other stakeholders have a valuable role to play in ensuring pharmacies in their state
Fig. 1. Overall percentage of U.S. community pharmacies with a CLIA-waiver, by state. Sources: Centers for Disease Control and Prevention (CDC). CLIA Laboratory Search. Retrieved from: http://wwwn.cdc.gov/clia/Resources/LabSearch. aspx; Accessed 03.05.15. National Association of Chain Drug Stores. Chain Member Fact Book, 2014–2015. July 2015.
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are aware of the opportunities that exist. Additional efforts to create template protocols and CPAs may further help pharmacies by lowering the activation barrier of getting involved. Limitations One limitation to this research is that data pulled for the study represent different points in time. For example, the number of total community pharmacies in the country was pulled from the most recent NACDS Facts Book that reports data from 2013. The current CLIA-waived facilities data was pulled in May of 2015. It would be ideal if the timing of these datasets were synchronized; however, we do not believe there would be substantial variance per state, and thus believe the data provide a useful benchmark and comparison across states. Additionally, the assumption is made that every self-reported pharmacy with a CLIA-waiver is actively providing CLIA-waived tests. Some pharmacies that obtain such waiver may in fact not provide any test, or have an extremely limited test menu. Additional research on the types of tests that are provided in pharmacies, relative to other settings, is warranted, as well as a comparison of location in rural areas and hours of operation across settings. Conclusion Community pharmacies in the U.S. are leading facilities for CLIA-waived laboratories. Substantial state-level variations are observed in the percentage of pharmacies with CLIA Certificates of Waiver, and these differences may be driven by restrictions in state law or regulations. References 1. Centers for Disease Control and Prevention (CDC). Good laboratory practices for waived testing sites. MMWR; November 11, 2015. p. 1. Available from: http://www.cdc.gov/mmwr/PDF/rr/rr5413.pdf. Accessed July 2015. 2. U.S. Food and Drug Administration. Clinical Laboratory Amendments (CLIA) – currently waived analytes. Available from: http://www.accessdata.fda. gov/scripts/cdrh/cfdocs/cfclia/analyteswaived.cfm. Accessed July 2015. 3. Centers for Medicare and Medicaid Services (CMS). CLIA Database Information – 1993–2014; November 2014. Available from: http://www.cms.gov/Regula tions-and-Guidance/Legislation/CLIA/Downloads/ summary_chart1993_to2013.pdf. Accessed July 2015.
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4. Centers for Medicare and Medicaid Services (CMS). Laboratories by Type of Facility. CLIA Update; November 2014. Available from: http://www.cms. gov/Regulations-and-Guidance/Legislation/CLIA/ Downloads/factype.pdf. Accessed July 2015. 5. Rosenfeld LA, Etkind P, Grasso A, Adams AJ, Rothholz MC. Extending the reach: local health department collaboration with community pharmacies in Palm Beach County, Florida for H1N1 influenza pandemic response. J Public Health Manag Pract 2011;17:439–448. 6. Rubin SE, Schulman RM, Roszak AR, Herrmann J, Patel A, Koonin LM. Leveraging partnerships among community pharmacists, pharmacies, and health departments to improve pandemic influenza response. Health Secur 2014;12:76–84. 7. Centers for Disease Control and Prevention. Place of influenza vaccination among adults – United States, 2010-11 influenza season. MMWR; June 17, 2011. p. 782. 8. Akinwale TP, Adams AJ, Dering-Anderson AM, Klepser ME. Pharmacy-based point-of-care testing for infectious diseases: considerations for the pharmacy curriculum. Curr Pharm Teach Learn 2015;7: 131–136. 9. Gubbins PO, Klepser ME, Dering-Anderson AM, et al. Point-of-care testing for infectious diseases: opportunities, barriers, and considerations in community pharmacy. J Am Pharm Assoc 2014;54: 163–171. 10. Klepser ME, Adams AJ, Klepser DG. Antimicrobial stewardship in outpatient settings: leveraging innovative physician-pharmacist collaborations to reduce antibiotic resistance. Health Secur; 2015;166–173. 11. Roberts GE, Rubin SE, Smith JK, Adams AJ, Klepser DG. Public health perceptions of community pharmacy partnership opportunities. J Public Health Manag Pract; 2015;413–415. 12. Weidle PJ, Lecher S, Botts LW, et al. HIV testing in community pharmacies and retail clinics: a model to expand access to screening for HIV infection. J Am Pharm Assoc 2014;54:486–492. 13. Darin KM, Klepser ME, Klepser DE, et al. Pharmacist-provided rapid HIV testing in two community pharmacies. J Am Pharm Assoc 2015;55:81–88. 14. The Hepatitis C Trust. Pharmacy-based testing for hepatitis B and hepatitis C. Available from: http:// www.hcvaction.org.uk/sites/default/files/resources/ Pharmacy-based%20testing%20for%20hepatitis% 20B%20and%20hepatitis%20C%20%28hep%20c %20trust%29.pdf. Accessed July 2015. 15. Snella KA. Pharmacy- and community-based screenings for diabetes and cardiovascular conditions in high-risk individuals. J Am Pharm Assoc 2006;46:307–317. 16. Fera T, Bluml BM, Ellis WM, Schaller CW, Garrett DG. The Diabetes Ten City Challenge: interim clinical and humanistic outcomes of a multisite pharmacy diabetes care program. J Am Pharm Assoc 2008;48:181–190.
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17. North Sheffield Primary Care Trust. Community Pharmacy Helicobacter Pylori ‘Test and Treat’ Enhanced Service Specification; December 2005. 18. Attard D, Azzopardi LM, Serracino-Inglott A. Proposing a Point-of-Care testing service for H. Pylori in community pharmacies. Retrieved from: https:// www.um.edu.mt/__data/assets/pdf_file/0010/194419/ Daniel_Attard_Poster.pdf. Accessed July 2015. 19. Midwest Pharmacy Workforce Research Consortium. 2014 National Pharmacist Workforce Survey. Available from: http://www.aacp.org/resources/research/ pharmacyworkforcecenter/Documents/FinalReport OfTheNationalPharmacistWorkforceStudy2014.pdf. Accessed July 2015. 20. Centers for Disease Control and Prevention (CDC). CLIA laboratory search. Available from: http:// wwwn.cdc.gov/clia/Resources/LabSearch.aspx. Accessed July 2015.
21. National Association of Chain Drug Stores. Chain Member Fact Book, 2014-2015; July 2014. 22. Pennsylvania Department of Health. Bureau of laboratories. Available from: http://www.portal.state.pa. us/portal/server.pt/community/laboratories/14158/ clinical_lab_licensure/556786. Accessed July 2015. 23. Adams AJ. Toward permissionless innovation in health care. J Am Pharm Assoc 2015;55:359–362. 24. Adams AJ, Klepser M, Klepser D. Physician-pharmacist collaborative practice agreements: a strategy to improve adherence to evidence-based guidelines. Evid Based Med Public Health 2015;1:e923. http:// dx.doi.org/10.14800/emph.923. 25. Centers for Disease Control and Prevention. Collaborative Practice Agreements and Pharmacists’ Patient Care Services. Available from: http://www.cdc. gov/dhdsp/pubs/docs/Translational_Tools_Pharma cists.pdf. Accessed July 2015.